Özer Etik Diğdem, Suna Nuretdin, Öcal Serkan, Selçuk Haldun, Dağlı Ülkü, Çolak Turan, Hilmioğlu Fatih, Boyacıoğlu Ahmet Sedat, Haberal Mehmet
From the Department of Gastroenterology, Baskent University Faculty of Medicine, Ankara, Turkey.
Exp Clin Transplant. 2019 Feb;17(1):52-58. doi: 10.6002/ect.2018.0095.
The introduction of direct-acting antiviral agents has allowed significant chances for treatment for difficult-to-treat populations. This study aimed to investigate the efficacy, tolerability, and safety of these therapies in both patients with end-stage renal disease and kidney transplant recipients with chronic hepatitis C virus infection.
This study was a retrospective analysis with prospective follow-up of patients. The antiviral combination of ombitasvir 25 mg, paritaprevir 75 mg, ritonavir 50 mg, and dasabuvir 50 mg was prescribed to patients with end-stage renal disease or kidney transplant recipients with noncirrhotic or compensated cirrhotic liver disease. The other antiviral combination consisted of sofosbuvir 400 mg and ledipasvir 90 mg, which was recommended to patients with decompensated cirrhosis or those who could not tolerate the first combination regimen. Ribavirin was given to all patients with genotype 1a hepatitis C virus infection. All clinical and laboratory data were recorded at week 4, at end of the treatment, and at 12 weeks after completion of treatment.
In terms of efficacy, sustained virologic response at 12 weeks was achieved in 94% of patients in the end-stage renal disease group and 92% of patients in the kidney transplant group. In terms of tolerability, antiviral treatment was well tolerated in both groups. Cardiac arrest and cerebrovascular accident were seen in the end-stage renal disease group; severe mucositis and glossitis were seen in the kidney transplant group. Hospitalization was needed in 2 patients for treatment of drug interactions with tacrolimus and sirolimus. Renal allograft function worsened in 2 patients, with 1 patient having biopsyproven antibody-mediated rejection.
We observed great efficacy and safety in both kidney transplant recipients and patients with end-stage renal disease with these agents in treatment of chronic hepatitis C. However, clinicians should remain aware of drug interactions and adverse events in this fragile patient population.
直接作用抗病毒药物的引入为难以治疗的人群带来了显著的治疗机会。本研究旨在调查这些疗法在终末期肾病患者和慢性丙型肝炎病毒感染的肾移植受者中的疗效、耐受性和安全性。
本研究是一项对患者进行前瞻性随访的回顾性分析。向终末期肾病患者或患有非肝硬化或代偿性肝硬化肝病的肾移植受者开具ombitasvir 25毫克、paritaprevir 75毫克、ritonavir 50毫克和dasabuvir 50毫克的抗病毒联合用药。另一种抗病毒联合用药由sofosbuvir 400毫克和ledipasvir 90毫克组成,推荐给失代偿性肝硬化患者或无法耐受第一种联合治疗方案的患者。所有基因型1a丙型肝炎病毒感染患者均给予利巴韦林。在第4周、治疗结束时和治疗完成后12周记录所有临床和实验室数据。
在疗效方面,终末期肾病组94%的患者和肾移植组92%的患者在12周时实现了持续病毒学应答。在耐受性方面,两组对抗病毒治疗的耐受性均良好。终末期肾病组出现心脏骤停和脑血管意外;肾移植组出现严重的口腔炎和舌炎。2名患者因与他克莫司和西罗莫司的药物相互作用需要住院治疗。2名患者的肾移植功能恶化,其中1名患者经活检证实为抗体介导的排斥反应。
我们观察到这些药物在肾移植受者和终末期肾病患者治疗慢性丙型肝炎方面具有很高的疗效和安全性。然而,临床医生应继续关注这一脆弱患者群体中的药物相互作用和不良事件。